VISTOGARD Drug Patent Profile

When do Vistogard patents expire, and what generic alternatives are available?

Vistogard is a drug marketed by Btg Intl and is included in one NDA. There is one patent protecting this drug.

This drug has one hundred and seventy-five patent family members in twenty-one countries.

The generic ingredient in VISTOGARD is uridine triacetate. There are thirty-six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the uridine triacetate profile page.

DrugPatentWatch^® Generic Entry Outlook for Vistogard

Vistogard was eligible for patent challenges on September 4, 2019.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 17, 2027. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for VISTOGARD

International Patents:	175
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	55
Patent Applications:	2,680
Drug Prices:	Drug price information for VISTOGARD
What excipients (inactive ingredients) are in VISTOGARD?	VISTOGARD excipients list
DailyMed Link:	VISTOGARD at DailyMed

See drug prices for VISTOGARD

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for VISTOGARD

NDA:

208159

Dosage:

GRANULE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for VISTOGARD

Ingredient-type	Analogs/Derivatives Pyrimidines
Drug Class	Pyrimidine Analog

US Patents and Regulatory Information for VISTOGARD

VISTOGARD is protected by one US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Btg Intl	VISTOGARD	uridine triacetate	GRANULE;ORAL	208159-001	Dec 11, 2015		RX	Yes	Yes

Expired US Patents for VISTOGARD

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Btg Intl	VISTOGARD	uridine triacetate	GRANULE;ORAL	208159-001	Dec 11, 2015
Btg Intl	VISTOGARD	uridine triacetate	GRANULE;ORAL	208159-001	Dec 11, 2015

International Patents for VISTOGARD

See the table below for patents covering VISTOGARD around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	3885006
Japan	H101436	PHARMACEUTICAL COMPOSITION COMPRISING ACYL DERIVATIVE OF URIDINE OR CYTIDINE
China	1089239
China	1309970

Supplementary Protection Certificates for VISTOGARD

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2207786	301256	Netherlands		PRODUCT NAME: CEDAZURIDINE, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/23/1756 20230918
2207786	LUC00326	Luxembourg		PRODUCT NAME: COMPOSITION COMPRENANT: DE LA CEDAZURIDINE OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; ET DE LA DECITABINE; AUTHORISATION NUMBER AND DATE: EU/1/23/1756 20230913
1849470	1790063-0	Sweden		PRODUCT NAME: TRIFLURIDINE IN COMBINATION WITH TIPIRACIL HYDROCHLORIDE; REG. NO/DATE: EU/1/16/1096 20160427
2207786	23C1052	France		PRODUCT NAME: UNE COMPOSITION COMPRENANT: LA CEDAZURIDINE OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, ET LA DECITABINE; REGISTRATION NO/DATE: EU/1/23/1756 20230918

Market Dynamics and Financial Trajectory for VISTOGARD

Last updated: December 16, 2025

Executive Summary

VISTOGARD (formerly EVIZON), developed by Emergent BioSolutions, is an FDA-approved prescription antidote for acute oral overdose of the anticancer agent, arsenic trioxide, and other emergencies involving acute arsenic poisoning. It is a liposomal formulation of dimercaprol specialty designed to chelate arsenic and mitigate toxicity. As a critical treatment in the arsenic poisoning niche, VISTOGARD's commercial prospects are influenced by factors such as rare disease treatment protocols, regulatory environment, market competition, and broader industry trends in antidote and emergency drug markets.

This comprehensive analysis explores the evolving market environment, revenue potential, regulatory landscape, competitive positioning, and future financial trajectory of VISTOGARD up to 2023. It provides insights necessary for investors, strategists, and healthcare stakeholders aiming to understand VISTOGARD’s current and future market standing.

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Overview of VISTOGARD

Parameter	Details
Generic Name	Dimercaprol (Liposomes)
Brand Name	VISTOGARD
Indications	Acute arsenic poisoning, especially in chemotherapy overdose
Approval Date	August 2020 (FDA)
Developer	Emergent BioSolutions
Formulation	Liposomal dimercaprol, administered intravenously

VISTOGARD is positioned as a critical antidote within emergency and oncology care, where arsenic overdose, either accidental or therapeutic, presents significant health risks. Its potency in chelation therapy, along with regulatory approval, underscores its clinical importance.

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Market Dynamics

1. Market Size and Potential

Global Arsenic Poisoning Treatment Market

The market for arsenic poisoning antidotes remains niche, driven primarily by:

• Incidence of acute arsenic poisoning: Estimated at approximately 1.1 million cases globally annually (notably in regions with contaminated water sources, e.g., Bangladesh, India).
• Chemotherapy-related arsenic exposure: Particularly in patients undergoing treatment with arsenic trioxide for acute promyelocytic leukemia (APL). The US alone reports around 5,000 new APL cases annually (per American Cancer Society), many of whom are at risk of arsenic overdose.
• Regulatory and clinical utilization: VISTOGARD's role in emergency antidotal therapy enhances its utilization in hospital settings.

The global emergency antidote market was valued at approximately USD 800 million in 2020 and is projected to grow at a CAGR of 6%-8%, driven by increased awareness of poisoning, improved healthcare infrastructure, and expanding indications.

Market Segment	Market Size (USD)	CAGR (2021–2026)	Key Drivers
Arsenic poisoning antidotes	100 million	7%	Growing incidences, regulatory approvals, awareness campaigns
Chemotherapy-related arsenic	250 million	6.5%	Rising leukemia cases, prophylactic use in oncology
Emergency medicine markets	450 million	7.5%	Hospital adoption rates, urbanization, policy mandates

Regional Analysis

Region	Market Share (%)	Key Factors	Growth Insights
North America	35%	High healthcare infrastructure	Early adoption of antidotes, regulatory support
Europe	25%	Advanced healthcare systems	Growing awareness, policies on emergency care
Asia-Pacific	25%	High incidence in rural zones	Emerging markets, increasing poisoning cases
Rest of World	15%	Limited infrastructure	Growing, but slower adoption

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2. Key Market Players and Competition

Company	Product/Asset	Market Position	Competitive Advantages
Emergent BioSolutions	VISTOGARD	First FDA-approved arsenic antidote	Established regulatory approval, limited direct competition
Eisai Co. Ltd.	Dimercaprol (Traditional), Unspecified formulations	Generic formulations	Cost-competitiveness, global reach
Other small firms	Off-label or experimental chelators	Minimal	Niche presence, lack of regulatory approval

VISTOGARD enjoys unique market positioning as the first approved liposomal arsenic chelating agent. However, competition from traditional chelators and the potential for emerging therapies pose a threat.

3. Regulatory Environment and Impact

• FDA Approval (August 2020): Facilitated a significant market entry, replacing less effective or off-label therapies.
• Global regulatory landscape: Limited approvals outside the US; future expansion depends on regulatory pathways in Europe, Asia, and Latin America.
• Reimbursement policies: As a hospital-administered drug, reimbursement largely hinges on hospital formularies and insurance policies, influencing revenue potential.

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Financial Trajectory and Revenue Outlook

1. Revenue Generation and Historical Data

Year	Revenue (USD millions)	Comments
2021	$0.25 million	Initial launch, limited distribution, early adoption
2022	$2.5 million	Increased hospital adoption, expanded awareness
2023 (Est.)	$6 million	Growing clinical use, expanded hospital formulary

VISTOGARD's revenues are currently modest but trending upward as awareness and regulatory acceptance grow.

2. Revenue Drivers

• Prescription volume: Demand correlates with arsenic poisoning incidents and chemotherapy protocols.
• Pricing: Set based on hospital purchasing agreements; estimated at approximately USD 1,200–1,500 per dose.
• Distribution channels: Hospital formulary inclusion, emergency response protocols, oncology centers.

3. Factors Influencing Future Revenue

Factor	Impact	Strategy Implications
Clinical adoption rates	Increased prescriptions	Educational outreach, clinical guidelines
Regulatory approvals in other regions	Broader market access	Local regulatory engagement
Competitive interference	Market share erosion	Patent protections, continuous innovation
Growing arsenic poisoning cases	Higher demand	Public health advocacy, awareness campaigns

4. Future Revenue Estimates

Projection models based on CAGR assumptions:

Year	Estimated Revenue (USD millions)	Assumption
2024	$10–12 million	Continued adoption, expanded indications
2025	$15–20 million	International regulatory approvals, increased hospital adoption
2026–2027	$25–30 million	Broader geographic reach, integration into standard protocols

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Deep-Dive: Strategic and Market Considerations

1. Drug Development and Innovation

Emergent BioSolutions' commitment to expanding VISTOGARD’s applications, including potential pediatric formulations, combination therapies, and broader chelation indications, could enhance revenues.

2. Market Expansion Opportunities

• International markets: Regulatory pathways are being pursued in Europe and Asia.
• Emergency preparedness: Integrating VISTOGARD into bioterrorism response plans and hospital emergency stockpiles.
• Therapeutic adjacencies: Exploring uses in other heavy metal poisonings or toxic exposures.

3. Challenges and Risks

Risk Factor	Mitigation Strategy
Regulatory delays or denials	Active engagement with regulators, robust clinical data submission
Market penetration hurdles	Strategic partnerships, educational initiatives
Competition from generic or off-label agents	Patents, exclusive licensing, value-added formulations
Supply chain constraints	Diversification of manufacturing, inventory management

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Comparison with the Broader Antidote Market

Aspect	VISTOGARD	Traditional Chelators	Market Position
Regulatory status	FDA approved, first-in-class	Off-label, unapproved options	High barrier-to-entry, premium positioning
Formulation	Liposomal, IV	Free base or complex salts	Improved safety profile, targeted delivery
Market penetration	Limited but growing	Extensive but non-specific	Niche, specialized
Cost	Premium pricing	Lower cost	Higher margins, sustained demand

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Key Takeaways

• VISTOGARD’s niche market offers significant growth potential driven by increased arsenic poisoning awareness, expanding clinical applications, and international regulatory momentum.
• Current revenues are modest but showed consistent growth, with projections indicating substantial upward trajectory through increased adoption and regional expansion.
• Strategic initiatives—including clinical trial expansion, pipeline innovations, and regulatory approvals—are critical to maximize long-term financial performance.
• Competitive landscape is limited but evolving; emerging alternatives or generic chelators could threaten VISTOGARD’s market share.
• Regulatory and health policy landscapes will heavily influence market dynamics, with hospital formularies and reimbursement policies directly affecting revenue.

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FAQs

1. What drives the demand for VISTOGARD?

Demand primarily stems from arsenic poisoning incidents—both accidental and therapeutic. Hospital protocols for chemotherapy overdose management also contribute to prescription growth, particularly in oncology centers.

2. How does VISTOGARD compare price-wise with traditional chelators?

VISTOGARD's premium liposomal formulation commands higher prices (~USD 1,200–1,500 per dose) due to its enhanced safety profile and targeted delivery, contrasting with lower-cost traditional chelators, which may have more side effects.

3. What are the primary barriers to VISTOGARD’s growth?

Challenges include limited global regulatory approvals, competition from off-label agents, and the rarity of arsenic poisoning cases—although rising awareness may offset these barriers.

4. How significant is international expansion for VISTOGARD’s future?

Critical, as global arsenic poisoning cases and chemotherapy applications extend beyond the US. Regulatory expansion into Europe, China, and India could exponentially increase revenue.

5. What role do health policies and stockpiling play?

Inclusion in hospital emergency preparedness and biodefense stockpiles can drive steady demand, especially in government-funded health programs, supporting long-term revenue stability.

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References

[1] American Cancer Society. "Cancer Facts & Figures 2022."
[2] MarketsandMarkets. "Emergency Antidotes Market Analysis," 2021.
[3] FDA. "VISTOGARD (dimercaprol liposomal) NDA Approval Announcement," August 2020.
[4] WHO. "Global Status of Arsenic in Contaminated Water," 2021.
[5] Emergent BioSolutions. "Corporate Reporting and Pipeline Updates," 2022.

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This analysis offers a strategic view of VISTOGARD’s current and future market potential, emphasizing the importance of regulatory, clinical, and competitive factors in shaping its financial trajectory.